Clinical trial

Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05642663

Active, not recruitingNot applicableObservational

What this study is about

Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion Criteria: * Patients with grade II obesity (BMI ≥ 35 kg/m\^2) with one or more associated comorbidities; * Patients with grade III obesity (BMI ≥ 40 kg/m\^2) regardless of associated diseases; * Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler; * The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up. Exclusion Criteria: * Impossibility of collecting data related to the surgical procedure * Impossibility of contact with the patient to obtain the informed consent form

Treatments and study arms

Stapler

Device

Stapling performed with ALTUS Powered Stapler

Primary outcomes

Safety - Conversion to open surgeryIntraoperative

Number of conversions to open surgery during the index procedure

Safety - Number of reinterventionsUp to 1 week

Number of reinterventions within 1 week after the procedure

Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding30 days

Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure

Safety- Fistula formation30 days

Presence of fistula within 30 days after procedure

Safety - Stenosis90 days

Detection of stenosis within 90 days after procedure

Performance - Procedure SuccessIntraoperative

Defined by completion of technique with the device for its intended use

Performance - Cicatrization of staple line90 days

The absence of oozing/bleeding at the staple line

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital IGESP🇧🇷 São Paulo, São Paulo, Brazil

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